BPH (Benign Prostatic Hyperplasia)NCT07381127
INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms
A study testing INTUPRO ionic fluid in people with BPH (Benign Prostatic Hyperplasia) and BPH, run by inTumo Therapeutics, Inc. at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH). The main questions it aims to answer are: Can INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), BPH, BPH With Other Lower Urinary Tract Symptoms
- What is being tested?
- INTUPRO ionic fluid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Male patient aged 45 years or older
- Prostate volume greater than 30 grams
- An International Prostate Symptom Score (IPSS) of 12 or higher
- Presence of obstructive urinary symptoms, such as difficulty starting urination, leakage of urine after voiding, or a feeling of incomplete bladder emptying.
- This criterion may include patients who have previously been diagnosed with prostate cancer and completed treatment, but are experiencing urinary problems.
- Life expectancy of at least 3 months
- Ability to understand the study information and provide written informed consent
- Willingness and ability to comply with all study requirements, including procedures, clinical assessments, and follow-up visits
Who cannot join
- Urethral stricture
- Bladder stones
- Prostate volume 120 grams or greater
- Presence of a prostate median lobe
- History of bladder cancer or kidney cancer, and/or prior surgery related to these conditions
- Previous radiation therapy to the pelvic region
Show all 15Show fewer
- Prior invasive surgical treatment for BPH symptoms
- The Principal Investigator believes the patient would not tolerate the procedure
- Presence of a cognitive impairment that, in the opinion of the Principal Investigator, would interfere with the patient's ability to provide reliable data or to safely complete the study
- Bleeding disorders
- Known allergy or intolerance to MRI contrast agents required for imaging used to evaluate treatment effectiveness after ionic fluid application
- Other significant concurrent medical conditions that, in the investigator's judgment, could prevent clinical benefit from the procedure or could place the patient or study objectives at risk (including, but not limited to, active infection, kidney dysfunction, or significant comorbidities)
- Significant medical or psychiatric illness
- Participation in another clinical study involving a device, drug, or procedure that has not been completed or that could affect the outcomes of this study
- Inability or unwillingness to undergo MRI examinations during the study period for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koç University Hospital Research Center
Istanbul, 34010
Yakup Kordan, MD, Professor, +905324460737, y.kordan@kuh.ku.edu.tr
About this study
Official title: A Study to Evaluate the Safety and Efficacy of Ionic Fluid in Treating Symptoms in Patients With Benign Prostatic Hyperplasia. A Prospective, Single-arm, Single-center Clinical Study.
The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH).
The main questions it aims to answer are:
Can INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO treatment lower or minimize waking during sleep to urinate? Can INTUPRO reduce urinary hesitancy, urgency and frequency?
Participants will:
Receive INTUPRO treatment on Day 1. Visit at Day 30 and Day 90 for checkups, tests and Prostate MRI.
Read the detailed description
The main goal of this study is to determine how well INTUPRO improves urinary symptoms in patients with benign prostatic hyperplasia (BPH). Effectiveness will be measured by changes in the International Prostate Symptom Score (IPSS), a standard questionnaire used to assess urinary symptoms.
Another goal of this study is to evaluate the safety of INTUPRO. This includes monitoring and recording all side effects, complications, or other medical problems that occur during the procedure and during the follow-up period after treatment.
This study is planned to last approximately one year; each patient will be followed for 3 months after treatment. Enrollment of 30 patients is expected.
- Being tested
- INTUPRO ionic fluid
- Keywords
- procedure, needle, benign prostate hyperplasia, moderate sedation, outpatient
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTUPRO ionic fluidDevice
Under TRUS imaging, a fixed dose of the ablative agent will be administered to patients by the physician via needle. Each patient will receive a total of 4-10 mL ionic fluid , administered as two separate 2-5 mL injections into each side of the prostatic urethra.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Under TRUS guidance, a fixed dose of the ablative agent will be administered to patients. Each patient will receive a total of 4-10 mL of ionic fluid, administered as two separate 2-5 mL injections into each side of the prostatic urethra. Receives: Device: INTUPRO ionic fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Symptoms (IPSS Score)
The change in the International Prostate Symptom Score (IPSS) from baseline will be evaluated after treatment. IPSS scores recorded at the screening visit will be compared with scores obtained at the 1-month and 3-month follow-up visits. A reduction in the IPSS score at 1 month and 3 months compared with baseline will be considered a primary outcome measure.
Measured: 3 months
Procedure-Related and Post-Procedure Complications
Complications related to the procedure and the postoperative period will be assessed at 1 day, 1 month, and 3 months after treatment. The following complications will be specifically monitored:
- Urinary retention
- Urinary tract infection, suggested by a positive urine culture
- Urosepsis
- Blood in the urine (hematuria)
- Perineal hematoma
Measured: 3 months
Secondary outcomes (9)
Procedure-Related Pain (Wong-Baker Pain Scale)
Pain related to the procedure will be assessed using the Wong-Baker Pain Scale on the day of treatment (Day 1), and at the 1-month and 3-month follow-up visits. Pain scores at follow-up visits will be compared with the pain level recorded on the day of the procedure.
Measured: 3 months
Urinary Incontinence Symptoms (ICIQ-UI)
Changes in urinary incontinence symptoms will be evaluated using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Scores will be recorded at baseline, 1 month, and 3 months after treatment, and follow-up scores will be compared with baseline values.
Measured: 3 months
Sexual Function (IIEF Score)
Changes in erectile function will be assessed using the International Index of Erectile Function (IIEF). Scores will be collected at baseline, 1 month, and 3 months, and compared with baseline measurements.
Measured: 3 months
Retrograde Ejaculation
The proportion of patients reporting retrograde ejaculation after the procedure will be recorded at the 1-month and 3-month follow-up visits.
Measured: 3 months
Quality of Life Related to Urinary Symptoms (IPSS-QoL)
Changes in quality of life related to urinary symptoms will be assessed using the IPSS Quality of Life (IPSS-QoL) score. Measurements will be taken at baseline, 1 month, and 3 months, and follow-up scores will be compared with baseline values.
Measured: 3 months
Uroflowmetry
Uroflowmetry measurements (Qmax - maximum flow rate, mL/s) will be collected at the 1-month and 3-month follow-up visits and compared with baseline values.
Measured: 3 months
Pressure-Flow Study (If Performed)
In patients who undergo pressure-flow studies, Detrusor pressure at Qmax (Pdet@Qmax) will be recorded at baseline and, if available, at the 1-month and 3-month follow-up visits, and compared with baseline values.
Measured: 3 months
Presence of prostate tissue ablation
The presence and extent of prostate tissue ablation (complete, partial, none) will be evaluated using MRI (or other imaging methods, if applied) at baseline, 1 month, and 3 months. Imaging findings will be compared across time points.
Measured: 3 months
Post-Procedure Urinary Catheterization Time
The total duration of urinary catheter use after the procedure, measured in days, will be recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start4 Mar 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- inTumo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381127
- Sponsor's protocol ID
- INTUMO-003
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Ionic Fluid in Treating Symptoms in Patients With Benign Prostatic Hyperplasia. A Prospective, Single-arm, Single-center Clinical Study.
- ClinicalTrials.gov ID
- NCT07381127
- Acronym / sponsor ID
- INTUMO-003
- Keywords
- procedure, needle, benign prostate hyperplasia, moderate sedation, outpatient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- inTumo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH).
The main questions it aims to answer are:
Can INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO treatment lower or minimize waking during sleep to urinate? Can INTUPRO reduce urinary hesitancy, urgency and frequency?
Participants will:
Receive INTUPRO treatment on Day 1. Visit at Day 30 and Day 90 for checkups, tests and Prostate MRI.
Detailed description
The main goal of this study is to determine how well INTUPRO improves urinary symptoms in patients with benign prostatic hyperplasia (BPH). Effectiveness will be measured by changes in the International Prostate Symptom Score (IPSS), a standard questionnaire used to assess urinary symptoms.
Another goal of this study is to evaluate the safety of INTUPRO. This includes monitoring and recording all side effects, complications, or other medical problems that occur during the procedure and during the follow-up period after treatment.
This study is planned to last approximately one year; each patient will be followed for 3 months after treatment. Enrollment of 30 patients is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: INTUPRO ionic fluidUnder TRUS guidance, a fixed dose of the ablative agent will be administered to patients. Each patient will receive a total of 4-10 mL of ionic fluid, administered as two separate 2-5 mL injections into each side of the prostatic urethra. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Male patient aged 45 years or older
- This criterion may include patients who have previously been diagnosed with prostate cancer and completed treatment, but are experiencing urinary problems.
- Life expectancy of at least 3 months
- Ability to understand the study information and provide written informed consent
- Willingness and ability to comply with all study requirements, including procedures, clinical assessments, and follow-up visits
Key exclusion criteria (15 listed)
- Urethral stricture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTUPRO ionic fluidUnder TRUS imaging, a fixed dose of the ablative agent will be administered to patients by the physician via needle. Each patient will receive a total of 4-10 mL ionic fluid , administered as two separate 2-5 mL injections into each side of the prostatic urethra. | Device | Intervention arm |
Primary outcome
Change in Urinary Symptoms (IPSS Score)
Time frame: 3 months
The change in the International Prostate Symptom Score (IPSS) from baseline will be evaluated after treatment. IPSS scores recorded at the screening visit will be compared with scores obtained at the 1-month and 3-month follow-up visits. A reduction in the IPSS score at 1 month and 3 months compared with baseline will be considered a primary outcome measure.
Procedure-Related and Post-Procedure Complications
Time frame: 3 months
Complications related to the procedure and the postoperative period will be assessed at 1 day, 1 month, and 3 months after treatment. The following complications will be specifically monitored: * Urinary retention * Urinary tract infection, suggested by a positive urine culture * Urosepsis * Blood in the urine (hematuria) * Perineal hematoma
9 secondary outcomes
Procedure-Related Pain (Wong-Baker Pain Scale)
Time frame: 3 months
Urinary Incontinence Symptoms (ICIQ-UI)
Time frame: 3 months
Sexual Function (IIEF Score)
Time frame: 3 months
Retrograde Ejaculation
Time frame: 3 months
Quality of Life Related to Urinary Symptoms (IPSS-QoL)
Time frame: 3 months
Uroflowmetry
Time frame: 3 months
Pressure-Flow Study (If Performed)
Time frame: 3 months
Presence of prostate tissue ablation
Time frame: 3 months
Post-Procedure Urinary Catheterization Time
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Related trials for BPH (Benign Prostatic Hyperplasia)
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Koç University Hospital Research Center
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTUPRO ionic fluid in people with BPH (Benign Prostatic Hyperplasia) and BPH, run by inTumo Therapeutics, Inc. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary Symptoms (IPSS Score) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.